the effect of combination of traditional chinese medicine (tcm) and highly active antiretroviral therapy (haart) on immune reconstitution of hiv/aids patients

Conditions: Acquired Immune Deficiency Syndrome Virus; HIV Infections

Summary: immunity 1 (fuzheng 1) is composed of herbs which have tonic and detoxific function. the long-term clinical application has proved the safety and effect. it can improve the symptoms and signs in aids patients with the effective rate of 70% and can significantly improve the quality of life. it can also improve and stabilize immune function and inhibit viral replication. the basis study have shown that immunity 1 (fuzheng 1) can inhibit viral replication from multi-target, multi-link, enhance immune function, increase the secretion of il-2, ifn-γ, participate in immune regulation effect, enhance nk cell activity, promote cd3+cd4+t cell proliferation and increase macrophage phagocytes capacity.

* meng kun found that joint application of chuankezhi can enhance the number of cd4 cells and reduce side-effects of haart compared with haart alone. in order to verify the long-term efficacy of combination therapy, they carried out an clinical observations of three cases of patients who received combination therapy for over a period of 3 years, through the observation of three cases of patients, they found that cd3+cd4+t lymphocyte count were significantly increased and hiv-rna viral load were below 50copies for long-term, and without the occurrence of drug resistance. and the patient's symptoms and signs have also been significantly improved. * duan cheng yu analyses 334 cases of aids patients' clinical symptoms, signs and karnofsky score, and cd3+cd4+ t lymphocyte count before and after treatment. the patients all take "kang ai bao sheng" capsules for 3 months. the results showed that 334 cases of patients receiving traditional chinese and western medicine treatment shows improvement in symptoms and signs, increase in cd3+cd4+ t lymphocyte count. they proposed that combination of traditional chinese and western medicine can improve symptoms, enhance immunity function and improve the quality of life of aids patients. * in order to observe the effect of combination of tcm and haart on hiv/aids patients, zhang ai-min divided 63 cases of aids into 3 groups. 20 cases received tcm treatment and 22 cases received combination of tcm and haart, 21 cases received western medicine. the patients' symptoms, signs, karnofsky score points, cd3+cd4+t lymphocyte counts and hiv-rna viral load were recorded and compare the difference between the 3 groups. the results showed that combination treatment can more effectively improve the immune function of hiv/aids patients, reduce hiv-rna viral load, and improve the patients' symptoms, signs and the quality of life. * immunity 1 (fuzheng 1) is composed of herbs which have tonic and detoxific function. the long-term clinical application has proved the safety and effect. it can improve the symptoms and signs in aids patients with the effective rate of 70% and can significantly improve the quality of life. it can also improve and stabilize immune function and inhibit viral replication. the basis study have shown that immunity 1 (fuzheng 1) can inhibit viral replication from multi-target, multi-link, enhance immune function, increase the secretion of il-2, ifn-γ, participate in immune regulation effect, enhance nk cell activity, promote cd3+cd4+t cell proliferation and increase macrophage phagocytes capacity. * through the clinical trials, we are going to evaluate the efficacy and safety of combination of tcm and haart on immune reconstitution of hiv/aids patients.

Eligibility criteria:
inclusion criteria: * hiv antibody-positive, confirmed by western blot test * cd 4 count ≤ 350 cells / ul * age ≥ 18 years old and ≤ 70 years old * voluntary participated in this study, signed informed consent form, and could be followed-up exclusion criteria: * serious opportunistic infections were not brought under control (pneumocystis carinii pneumonia, meningitis, esophageal candidiasis, lymphoma, toxoplasma encephalopathy, tuberculosis, etc.) before the experiment * participated in clinical trials of other drugs within one month before the experiment * received antiretroviral therapy or are anti-hiv drugs such as nucleoside reverse transcriptase inhibitors (nrtis), non-nucleoside reverse transcriptase inhibitors (nnrtis), protease inhibitors (pis) and fusion-inhibiting agent (fis), integrase inhibitors, inhibitors penetration within one month before the experiment * received immunomodulatory treatment within one month before the experiment wbc \<2 × 10 9 / l, n \<1.0 × 10 9 / l, hb \<90g / l, plt \<75 × 10 9 / l, liver and kidney dysfunction (ast, alt, t-bil ≥2 times of upper limit of the reference value or creatinine ≥ 2 times of the upper limit of reference value) * patients with pancreatitis or active gastric ulcer * patients with obvious active diseases in respiratory system, digestive system, circulatory system, blood system, neuroendocrine system, or genitourinary system diseases * persons suffering from autoimmune diseases * cancer patients which need chemotherapy * pregnant or lactating women, and did not use safe contraceptive measures for women of child-bearing age, as well as the male that can not take a reasonable method of contraception in trial period * hypersensitive people * patients with dysgnosia or language barriers, which can not fully understand the test or cooperate well

Keywords: adis complementary therapies